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NCT02719574 · ClinicalTrials.gov registry record · Phase 1
Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation
A Phase 1 study, sponsored by Forma Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 336
- Enrollment target
NCT02719574 is a Phase 1 study that has completed, run by Forma Therapeutics. The registered enrollment target is 336 participants.
The verdict
NCT02719574, a Phase 1 study, has completed, sponsored by Forma Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 336 participants
- Enrollment target
Study Summary
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states.
Interventions
- DRUG Azacitidine
- DRUG Cytarabine
- DRUG FT-2102 (olutasidenib)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 336 participants |
| Start Date | 2016-04-30 |
| Est. Completion | 2024-01-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02719574
The ClinicalTrials.gov registry entry for NCT02719574 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 336 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forma Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Azacitidine is the first listed.
NCT02719574 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02719574 about?
NCT02719574 is a clinical study titled "Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation". This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 ...
What is the current status of trial NCT02719574?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 336 participants. The study started on 2016-04-30. Estimated completion is 2024-01-24.
What interventions are being tested in trial NCT02719574?
The interventions under investigation include: Azacitidine (DRUG), Cytarabine (DRUG), FT-2102 (olutasidenib) (DRUG).
Who is sponsoring clinical trial NCT02719574?
This trial is sponsored by Forma Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
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